(93 days)
The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
The Certas Plus Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Certas Plus Programmable Valve, to another body cavity where it is subsequently absorbed. The Certas Plus Programmable Valves can be set to eight different performance settings for intraventricular pressure and drainage of CSF. The performance settings of the valves can be set preoperatively and can also be noninvasively changed postimplantation by using the Certas Tool Kits. The Certas Tool Kits employ magnetic force to select one of eight settings.
The provided document is a 510(k) summary for the Certas Plus Programmable Valves, which are medical devices used for the management of hydrocephalus. This specific document outlines the regulatory review of a proposed modification to an already legally marketed device.
The document does not describe a study that proves the device meets clinical acceptance criteria in the way typically seen for novel medical imaging or diagnostic AI devices. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices after minor modifications (material changes and dimensional/tolerance changes). Therefore, much of the requested information regarding clinical study design, ground truth establishment, expert adjudication, or MRMC studies will not be present in this type of submission.
Here's a breakdown based on the information available and what is not applicable given the nature of the submission:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria and performance are reported for bench and biocompatibility testing, not clinical performance in patients.
| Test | Acceptance Criteria (Implicit: "Pass") | Reported Performance |
|---|---|---|
| Accelerated Aging for Shelf Life Testing per ASTM F1980 | Device maintains integrity and functionality over its claimed shelf life. | Pass |
| Functional Testing per ISO 7197 | Device performs its intended function (e.g., constant intraventricular pressure, CSF drainage) within specified parameters. | Pass |
| Functional Testing per ASTM F647 | Device performs its intended function within specified parameters. | Pass |
| MRI Testing per ISO/TS 10974 | Device is safe and performs as intended in an MRI environment (e.g., MR conditional). | Pass |
| X-Ray Testing per ASTM F640 | Device is visible and its characteristics can be assessed via X-ray. | Pass |
| MTS Cytotoxicity per ISO 10993-5 | No cytotoxic effects observed. | Pass |
| Guinea Pig Maximization Sensitization Study per ISO 10993-10 | No sensitization observed. | Pass |
| Intracutaneous Irritation Study in Rabbits per ISO 10993-10 | No irritation observed. | Pass |
| Acute Systemic Toxicity Study in mice per ISO 10993-11 | No acute systemic toxicity observed. | Pass |
| Rabbit Pyrogen Study per United States Pharmacopeia 42 – NF 37 | No pyrogenic response observed. | Pass |
| Subcutaneous Implantation Studies in Rabbits, 1 and 4 weeks per ISO 10993-6 | No adverse tissue reactions at the implantation site. | Pass |
| Systemic Toxicity and Local Effects Study in Rabbits following Subcutaneous Implantation 13 weeks per ISO 10993-6 and ISO 10993-11 | No systemic toxicity or significant local effects observed over 13 weeks. | Pass |
| Bacterial Reverse Mutation Study per ISO 10993-3 and ISO/TR 10993-33 | No mutagenic effects observed. | Pass |
| In Vitro Mouse Lymphoma Study per ISO 10993-3 and ISO/TR 10993-33 | No genotoxic effects observed. | Pass |
| Hemolysis on Extract Study per ISO 10993-4 and ASTM F756 | No significant hemolysis observed. | Pass |
2. Sample sizes used for the test set and the data provenance:
- Test set sample size: Not explicitly stated in terms of number of devices. The document mentions "production equivalent devices" were used for testing, implying multiple units were tested for each performance and biocompatibility assessment. Specific quantities are not provided, as this is a summary.
- Data provenance: Not applicable in the context of clinical patient data. The data comes from laboratory bench tests and biocompatibility studies on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies involving the interpretation of medical images or diagnostic outputs by human experts. This submission focuses on the physical and functional properties of an implantable device through bench and biocompatibility testing. The "ground truth" for these tests would be the established scientific and engineering principles and the predefined pass/fail criteria of the specified ASTM/ISO standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as there are no human interpretations or diagnostic outcomes to adjudicate. Test results are objective (e.g., chemical analysis, physical measurements, functional outputs).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. MRMC studies are used for evaluating diagnostic AI tools where human readers (e.g., radiologists) interpret cases with and without AI assistance to assess the AI's impact on their performance. The Certas Plus Programmable Valves are an implantable device, not a diagnostic AI tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance and biocompatibility testing is based on:
- Standardized test methods: Adherence to established ASTM, ISO, and USP standards for device function, material properties, and biological safety.
- Predefined pass/fail criteria: Each test has specific criteria that the device must meet to be deemed compliant.
8. The sample size for the training set:
This is not applicable. This is a physical medical device, not an AI model or algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
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February 1, 2023
Integra LifeSciences Production Corporation Amanda Erwin Manager, Regulatory Affairs 11 Cabot Boulevard Mansfield, Massachusetts 02048
Re: K223330
Trade/Device Name: Certas Plus Programmable Valves Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: October 31, 2022 Received: November 3, 2022
Dear Amanda Erwin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature includes the name "Adam D. Pierce -S" on two lines. The signature also includes the date "2023.02.01" and the time "11:59:50-05'00'".
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223330
Device Name Certas Plus Programmable Valves
Indications for Use (Describe)
The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 807.92(a) (1) Submitter Information | |
|---|---|
| Name and Address | Integra LifeSciences Production Corporation11 Cabot BoulevardMansfield, MA 02048On behalf of:Integra LifeSciences Switzerland SARLFloor 2, Rue Girardet 29Le Locle, Neuchatel CH-2400Switzerland |
| Telephone number | (609) 627-9053 |
| Primary Contact | Amanda Erwin |
| Date Summary Prepared | February 1, 2023 |
| 807.92(a) (2) Name of Device | |
| Trade or Proprietary Name | Certas Plus Programmable Valves |
| Common Name | Central Nervous System Fluid Shunt and Components |
| Classification Name | Central Nervous System Fluid Shunt and Components(21 CFR 882.5550) |
| Device Class | II |
| Product Code | JXG |
| 807.92(a) (3) Predicate Information | |
| Predicate Device | Certas Plus Programmable Valves: K152152 and K182265Certas Plus Programmable Valves: K143111 (reference device) |
| 807.92(a) (4) Device Description |
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The Certas Plus Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Certas Plus Programmable Valve, to another body cavity where it is subsequently absorbed. The Certas Plus Programmable Valves can be set to eight different performance settings for intraventricular pressure and drainage of CSF. The performance settings of the valves can be set preoperatively and can also be noninvasively changed postimplantation by using the Certas Tool Kits. The Certas Tool Kits employ magnetic force to select one of eight settings.
807.92(a) (5) Indications for Use
The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
807.92(a) (6) Technological Characteristics Compared to Predicate
The proposed Certas Plus Programmable Valves have intended use, sterility, design principles and fundamental operation as the predicate valves. The proposed minor change in technological characteristics for the valves consists of a material change and minor dimensional and tolerance changes for various components. The changes do not raise any new questions of safety and/or effectiveness.
| Component Affected | Proposed Modification | Rationale |
|---|---|---|
| Various InternalComponents | Replacement ofPolyethersulfone(PES) withPolysulfone (PSU) inCertas PlusProgrammableValves for variousinternal components. | Polyethersulfone willno longer be availablefor Integra tomanufacture theimpacted internalcomponents with. |
| Replacement ofNylon with | Nylon will no longerbe used to | |
| Polysulfone (PSU) inCertas Plusprogrammable ValveNeedle Guard internalcomponent. | manufacture theimpacted Certas PlusProgrammable ValveInline Valve NeedleGuard internalcomponent with. | |
| Minor dimensionaland tolerance changesto internalcomponents. Adesign feature in theSmall and RightAngle Needle Guardswill also be removed. | The minordimensional andtolerance changes tothe internalcomponents havebeen made toaccommodate thematerial changes. Theremoval of the designfeature in the Smalland Right AngleNeedle Guards wasdone to remove adesign feature thatwas never utilized. | |
| Labeling | Updates made toreflect the proposedmaterial changes, aswell as administrativeupdates andcorrections. | Update labelling withnew material andadministrativeupdates and correctedinformation. |
| Inclusion of a PatientImplant Card and aPatient InformationLeaflet | A Patient ImplantCard and PatientInformation Leaflet isincluded as thedevices are MRconditional implants. | |
| 807.92(b) 1-2: Summary of Nonclinical and Clinical Testing Performed |
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The following performance testing has been conducted in support of the substantial equivalence determination. The testing utilized well-established methods, including those from FDA consensus standards. All testing was performed on production equivalent devices.
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| Performance Bench Test Results | |
|---|---|
| Test | Conclusion |
| Accelerated Aging for Shelf Life Testing perASTM F1980 | Pass |
| Functional Testing per ISO 7197 | Pass |
| Functional Testing per ASTM F647 | Pass |
| MRI Testing per ISO/TS 10974 | Pass |
| X-Ray Testing per ASTM F640 | Pass |
| Biocompatibility Testing Results | |
|---|---|
| Test | Conclusion |
| MTS Cytotoxicity per ISO 10993-5 | Pass |
| Guinea Pig Maximization Sensitization Study perISO 10993-10 | Pass |
| Intracutaneous Irritation Study in Rabbits per ISO10993-10 | Pass |
| Acute Systemic Toxicity Study in mice per ISO10993-11 | Pass |
| Rabbit Pyrogen Study per United StatesPharmacopeia 42 – NF 37 | Pass |
| Subcutaneous Implantation Studies in Rabbits, 1and 4 weeks per ISO 10993-6 | Pass |
| Systemic Toxicity and Local Effects Study inRabbits following Subcutaneous Implantation 13weeks per ISO 10993-6 and ISO 10993-11 | Pass |
| Bacterial Reverse Mutation Study per ISO 10993-3and ISO/TR 10993-33 | Pass |
| In Vitro Mouse Lymphoma Study per ISO 10993-3and ISO/TR 10993-33 | Pass |
| Hemolysis on Extract Study per ISO 10993-4 andASTM F756 | Pass |
There are no changes in sterility as a result of the proposed material changes and minor dimensional and tolerance changes; a sterilization equivalency assessment was performed comparing the proposed device to the predicate device and deemed acceptable.
No clinical studies were required as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of testing.
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807.92(b) (3) Conclusion
Based upon the intended use, design, comparison to the predicate device, and testing performed, Integra LifeSciences believes that the proposed modifications to the Certas Plus Programmable Valves do not raise any new questions of safety and effectiveness, and is therefore, substantially equivalent to the predicate Certas Plus Programmable Valves.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).